Medical Device Process Validation Procedure
The Medical Device Process Validation Procedure provides guidance on medical device process validations. The ISO 13485Process Validation Procedure applies to all medical device manufacturing processes requiring validation prior to the commercial release of product.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Medical Device Process Validation ProcedureThe Process Validation Procedure provides guidance on medical device process validations. The Procedure applies to all medical device manufacturing processes requiring validation prior to the commercial release of product.
Medical Device Process Validation Procedure - OverviewThe Process Validation Procedure is applied to medical device manufacturing processes where the output of a process cannot be verified through inspection or testing.
The Process Validation Procedure provides instruction for determining when process validation is required, validation pre-requisites, and overall strategy. The procedure also includes information on worst case product selection, validation lots, test methods and acceptance criteria. Medical Device Process Validation Procedure - ComplianceThe Process Validation Procedure is FDA QSR and ISO 13485:2016 compliant.
To learn more about our ISO 13485 Process Validation Procedure contact us at [email protected]
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